MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X45MM CANNULATED TRANSLATION SCREW; POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

Catalog Number 14-571445C

Device Problems Crack (1135); Material Twisted/Bent (2981)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2019-00561 to 3012447612-2019-00565.

Event Description

It was reported that during the procedure, the tip of two screwdrivers fractured during installation and the tulip heads on three screws cracked and splayed during final tightening.The tip of the second screwdriver was unable to be removed and remained lodged in the third screw head.The first two screws were removed while the third remained stuck with the driver tip in the patient's body.The case was completed using an alternate screwdriver and two new screws.A delay greater than thirty minutes was reported leading to further blood loss and anesthesia exposure.No further long-term effects on the patient are known at this time.This is report three of five.

Event Description

It was reported that during the procedure, the tip of two screwdrivers fractured during installation and the tulip heads on three screws cracked and splayed during final tightening.The tip of the second screwdriver was unable to be removed and remained lodged in the third screw head.The first two screws were removed while the third remained stuck with the driver tip in the patient's body.The case was completed using an alternate screwdriver and two new screws.A delay greater than thirty minutes was reported leading to further blood loss and anesthesia exposure.No further long-term effects on the patient are known at this time.This is report three of five.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.

• Brand Name: 5.5 TI 6.5X45MM CANNULATED TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9562178
• MDR Text Key: 174101579
• Report Number: 3012447612-2019-00563
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K123549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-571445C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other